SAN FRANCISCO, September 30, 2021 / PRNewswire / – Curebase, a company committed to democratizing access to clinical studies, again partnered this summer with InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, to test InBios SCoV-2 rapid IgG detection test. This research resulted in the Emergency Use Clearance from the FDA (EUA) for use in United States.
“Time and time again during the pandemic, the Curebase DCT model has proven effective in securing the EUA for a variety of tests,” said Tom lemberg, founder and CEO of Curebase. “Our team is very proud to have built an agile and high quality solution to help these innovative companies secure the EUA for their products. By locally activating points of care in the community to collect clinical data, such as drive-in testing sites, we can more easily and quickly obtain data for FDA requirements. We know there is a better way to effectively and efficiently conduct healthcare research, and our team does a tremendous job of advancing the global healthcare industry.
Working with Curebase, as part of a point-of-care clinical evaluation using whole blood collected from fingers from individuals 15 days of age or older after symptom onset, the SCoV-2 Detect Rapid Test InBios IgG accurately determined 96.9% (PPA) of those who were positive and 100% of those who were negative (NPA) for SARS-CoV-2 (COVID-19) IgG antibodies. The InBios assay includes all the reagents and controls needed to run 50 test samples with results in approximately 20 minutes.
This rapid test is intended to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or previous infection. The SCoV-2 Detect IgG rapid test should not be used to diagnose or rule out acute infection with SARS-CoV-2. Currently, it is not known how long antibodies persist after infection and whether the presence of antibodies confers protective immunity.
Although the SCoV-2 Detect IgG rapid test has not been authorized or approved by the FDA, it has been cleared for emergency use by the FDA under an EUA for use by authorized laboratories. This product has only been authorized to detect the presence of IgG antibodies against SARS-CoV-2, not for other viruses or pathogens. Emergency use of this product is only permitted for the duration of the declaration that there are circumstances that justify the authorization of emergency use of in vitro diagnostics for the detection and / or diagnosis of COVID -19 under Section 564 (b) (1) of the Federal Law. Food, Drug and Cosmetic Act, 21 USC § 360bbb3 (b) (1), unless the statement is terminated or the authorization is earlier revoked.
“The ultimate goal of these projects is to advance healthcare and save lives,” Lemberg said. “Our team is grateful for the opportunity to help InBios in this life-saving work and look forward to future opportunities to make health research more accessible to the world.”
Curebase decentralized clinical trial model ensures more diverse studies because unique populations can be quickly identified and included. The company’s virtual research sites also give physicians new and unique options to offer regardless of their location. The Curebase platform enables sponsors, CROs, and physicians in practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more effective clinical studies. We prove that clinical research can be dramatically accelerated if we empower physicians around the world to recruit patients from the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.
InBios International Inc. specializes in the design, development and manufacture of diagnostic tests for emerging infectious diseases and biological threats. Situated in Seattle, Washington, InBios offers premium products that are accurate, easy to use and cost effective. InBios is GMP Compliant, FDA Registered, USDA Licensed, and ISO 13485: 2016 Certified. For more information visit www.inbios.com.